PLX
Protalix BioTherapeutics, Inc.1.8100
+0.0700+4.02%
Dec 16, 4:00:00 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Q&A colors rollout, pipeline details
Q&A clarified Elfabrio's EU 4-week rollout faces country-by-country reimbursement delays, with uptake starting H2 2026 and Chiesi educating physicians. US promotions target naive and switch patients effectively. PRX-115 details surfaced: dosing arms up to every 8 weeks with methotrexate, potential immunogenicity edge in $2B+ gout market by 2031. PRX-119 update by Q2 end. No contradictions; answers reaffirm prepared remarks and 2026 guidance. Management stayed positive. Q&A added color, not bombshells. Investors eye EU momentum.
Key Stats
Market Cap
145.56MP/E (TTM)
22.63Basic EPS (TTM)
0.08Dividend Yield
0%Recent Filings
10-K
FY2025 results
Protalix posted FY2025 revenues of $52.8M from selling goods, down 2% y/y as Chiesi orders dipped $6.8M amid Elfabrio inventory swings while Pfizer Elelyso uptake jumped $5.6M to $18.2M and steady Fiocruz sales hit $11.1M; license/R&D added $0.9M. Q4 drove momentum with first PRX-115 Phase 2 patients randomized in the RELEASE gout study, ramping R&D 51% y/y to $19.6M. Cash burned $11.0M operationally but holds $30.3M. No debt. Regional hostilities threaten Israeli ops.
8-K
Elfabrio EU dosing win, $25M milestone
Protalix reported $52.7M total revenue for 2025, down slightly from 2024, with net loss of $6.6M driven by R&D ramp-up to $19.6M for PRX-115 Phase 2 gout trial now enrolling. EC approved Elfabrio's less burdensome 2mg/kg every-4-weeks dosing in EU, unlocking $25M Chiesi milestone that bolsters cash to ~$50M by April 2026. 2026 revenue guidance: $78M-$83M. Milestone fuels pipeline push.
8-K
EC approves Elfabrio E4W dosing
Protalix BioTherapeutics scored European Commission approval on March 9, 2026, for a 2 mg/kg every-4-weeks dosing regimen of Elfabrio in stable adult Fabry patients on ERT, extending infusions from biweekly. This eases patient burden while maintaining care. Protalix books a $25 million milestone from Chiesi. EU access ramps up ahead of Fabry Awareness Month.
8-K
CHMP backs Elfabrio E4W dosing
Protalix posted its February 2026 corporate presentation, spotlighting CHMP's positive opinion for Elfabrio's 2mg/kg every-four-weeks dosing in stable adult Fabry patients across the EU, pending EC approval by March end. This halves infusion frequency versus bi-weekly rivals, backed by BRIGHT study data showing sustained efficacy. Approval triggers $25M milestone from Chiesi. Cash runway extends to 1H/2027 cashflow positivity.
8-K
CHMP backs Elfabrio E4W dosing
Protalix and Chiesi scored a CHMP positive opinion on January 30, 2026, recommending Elfabrio's 2 mg/kg every-4-weeks dosing for stable adult Fabry patients in the EU. EC decision expected by March 2026; approval triggers Protalix's $25 million milestone from Chiesi. Less frequent infusions cut patient burden. EC approval not assured.
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